Endo's Testosterone Injection Finally Wins FDA Nod

Testosterone undecanoate for injection (Aveed) has received the FDA's approval for treating male hypogonadism on its third try, its manufacturer announced.

by John Gever John Gever,Deputy Managing Editor, MedPage Today
March 06, 2014

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Testosterone undecanoate for injection (Aveed) has received the FDA's approval for treating male hypogonadism on its third try, its manufacturer announced Thursday.

Endo Pharmaceuticals said the long-acting product was cleared for administration once at initiation of treatment, again at 4 weeks, and every 10 weeks afterward.

The approval came after the FDA and Endo finally agreed on a risk evaluation and mitigation strategy (REMS), aimed primarily at preventing severe post-injection reactions such as pulmonary oil microembolism (POME) and anaphylaxis.

Aveed is formulated with castor oil and benzyl benzoate, which the FDA believed were contributors to the reaction.

Under the now-approved REMS, patients must remain in the administering physician's office or clinic for at least 30 minutes after injection so that short-term reactions may be observed and treated. Other details of the REMS were not immediately available.

Concerns about these reactions led the FDA to turn down Endo's first application in 2008, calling it unapprovable.

In addition to the reaction risk, which will be noted as a boxed warning on Aveed's label, other potential adverse effects include worsened prostate enlargement, liver toxicity, peripheral edema, sleep apnea, and venous thrombosis. The label will also list less severe but more common side effects such as acne, fatigue, irritability, hormonal irregularities, mood swings, and insomnia.

Shortly after Endo announced the approval, the consumer group Public Citizen called on the FDA to reverse it, citing recent studies that suggest increased cardiovascular risk with testosterone products.

Sidney Wolfe, MD, who recently retired from Public Citizen but still takes a hand in its health-related activities, sent a letter Wednesday to FDA Commissioner Margaret Hamburg, MD, in which he took the agency to task for its handling of testosterone products.

He called the FDA "reckless" for refusing to immediately require a black-box warning about cardiovascular risk on all such products, and said the Aveed approval was "unsafe and unreasonable."